Ameditech Inc: Medical Device Recall in 2015 - (Recall #: Z-0506-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016

Product Classification:

Class III

Date Initiated: November 16, 2015

Date Posted: December 30, 2015

Recall Number: Z-0506-2016

Event ID: 72651

Reason for Recall:

Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

Status: Terminated

Product Quantity: 8,290 units

Code Information:

141971 142195 142397 142674 142997 144209 144463 150018 150883 151525 151526 152180 152741 153045 153150 153151 153211 153376 153650

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated